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Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Primary Purpose

Proteinuria, Kidney Dysfunction, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Azilsartan
Losartan
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring diabetic kidney disease, hypertension

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 30 to 70; Type 2 diabetes diagnosed according to American Diabetes Association guidelines has stable blood sugar control, and glycosylated hemoglobin is less than 7.5%; The patient's blood pressure Systemic Blood Pressure (SBP) >140 or Diastolic Blood Pressure (DBP) >90 mmHg, has not taken antihypertensive drugs or is taking non-ARB/ACEI antihypertensive drugs; Urine albumin/creatinine ratio>300mg/g. Exclusion Criteria: Type 1 diabetes; The patient is considered as non-essential hypertension, such as hypertension caused by renal hypertension or endocrine disease; Contraindications of ARB drugs, such as pregnancy status, bilateral renal artery stenosis, allergy to ARB drugs and their excipients; It is expected that dialysis treatment will be carried out within 6 months; Patients with malignant tumors; Patients with mental illness; The researcher believes that others are not suitable for this study.

Sites / Locations

  • the Second Afficiated Hospital, Zhejiang University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

azilsartan group

losartan group

Arm Description

the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day

the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day

Outcomes

Primary Outcome Measures

proteinuria
urinary protein

Secondary Outcome Measures

24 hour urine protein
24 hour total protein
blood pressure
bp
kidney function
creatine, Blood Urine Nitrogen
urinary albumin/ creatine
urinary albumin/ creatine

Full Information

First Posted
February 3, 2023
Last Updated
February 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05753696
Brief Title
Azilsartan in Patients With Diabetic Kidney Disease and Hypertension
Official Title
The Effect of Azilsartan in Patients With Diabetic Kidney Disease and Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypertension is the most common complication in patients with diabetes nephropathy. Strengthening blood pressure and blood sugar control is the basic treatment for patients with diabetes nephropathy. Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitor (ACEI) are the first line drugs recommended in domestic and international guidelines for diabetes patients to control hypertension. As a new ARB drug, azilsartan has been found to have better antihypertensive effect than other ARB drugs. However, due to the limited sample size and study time, azilsartan has no significant advantage over other ARB drugs in terms of renal protection effect, and has not been systematically studied in diabetes nephropathy population. This study is intended to evaluate the effect of azilsartan on proteinuria and blood pressure improvement in patients with diabetes nephropathy and hypertension through clinical randomized controlled study, so as to accumulate evidence-based evidence of azilsartan in the comprehensive management of heart and kidney protection in this group of people, and promote the development of comprehensive treatment for patients with metabolic disease and renal injury combined with hypertension. This study will compare the advantages and disadvantages of azilsartan and classical ARB drug losartan potassium in terms of proteinuria, blood pressure control and renal function protection in patients with diabetes nephropathy and hypertension; We propose that the main indicator is the change of urinary albumin/creatinine ratio relative to the baseline, and the secondary indicator is the change of 24-hour urinary protein relative to the baseline; Change of blood pressure relative to baseline; Renal function, electrolyte and blood glucose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria, Kidney Dysfunction, Blood Pressure, Diabetic Kidney Disease
Keywords
diabetic kidney disease, hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
azilsartan group
Arm Type
Experimental
Arm Description
the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day
Arm Title
losartan group
Arm Type
Active Comparator
Arm Description
the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day
Intervention Type
Drug
Intervention Name(s)
Azilsartan
Intervention Description
Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d
Primary Outcome Measure Information:
Title
proteinuria
Description
urinary protein
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
24 hour urine protein
Description
24 hour total protein
Time Frame
up to 16 weeks
Title
blood pressure
Description
bp
Time Frame
up to 16 weeks
Title
kidney function
Description
creatine, Blood Urine Nitrogen
Time Frame
up to 16 weeks
Title
urinary albumin/ creatine
Description
urinary albumin/ creatine
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 30 to 70; Type 2 diabetes diagnosed according to American Diabetes Association guidelines has stable blood sugar control, and glycosylated hemoglobin is less than 7.5%; The patient's blood pressure Systemic Blood Pressure (SBP) >140 or Diastolic Blood Pressure (DBP) >90 mmHg, has not taken antihypertensive drugs or is taking non-ARB/ACEI antihypertensive drugs; Urine albumin/creatinine ratio>300mg/g. Exclusion Criteria: Type 1 diabetes; The patient is considered as non-essential hypertension, such as hypertension caused by renal hypertension or endocrine disease; Contraindications of ARB drugs, such as pregnancy status, bilateral renal artery stenosis, allergy to ARB drugs and their excipients; It is expected that dialysis treatment will be carried out within 6 months; Patients with malignant tumors; Patients with mental illness; The researcher believes that others are not suitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhida chen, Dr
Phone
15168417788
Email
715264276@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhida Chen
Organizational Affiliation
The second afiliated hospital of zhejiang university, school of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Afficiated Hospital, Zhejiang University, School of Medicine
City
Hanzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhida Chen

12. IPD Sharing Statement

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Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

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